A lack of evidence to support the safety and efficacy of over-the-counter, antibacterial soaps was at the heart of rule changes on Friday that federal regulators have sought for three years.
The U.S. Food and Drug Administration issued its final rule (PDF) that essentially bans companies from being able to market antiseptic wash products that contain any of 19 active ingredients out of concerns long-term daily use could pose a number of health risks. The one-time costs of the rule change are projected to be between $106.3 million and $402.8 million, the FDA said.
Companies were unable to demonstrate the ingredients were more effective than plain soap and water in preventing illness or the spread of infection, the agency said. In its proposed rule back in 2013, the FDA gave soap manufacturers until this year to provide data that showed their products were safer and more effective than plain soap and water.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term.”
The FDA said it plans to submit additional data on three ingredients—benzalkonium chloride, benzethonium chloride and chloroxylenol—in the coming year. The final rule does not include a ban on those three ingredients at this time and has deferred making a determination for one year.
Government officials had been looking into antibacterial soap for the past several years after data suggested certain ingredients such as triclosan, an ingredient used in liquid soaps, and triblocarban, which is found in bar soaps, could increase the risk of hormone alteration. Data also suggested those ingredients may help in the development of antibiotic-resistant germs.
A number of manufacturers had already begun to remove the ingredients noted by the FDA from their products.
The American Cleaning Institute, the leading trade organization for soap and cleaning-product makers, released a statement in reaction to the rule, arguing consumer antibacterial soaps and washes continue to be safe and an effective means of preventing infection despite the FDA findings.
“Consumer antibacterial soaps and washes continue to be safe and effective products for millions of people every single day,” according to the ACI's statement. “Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection. Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”
The FDA's rule applies only to those consumer antibacterial washes and soaps that are used with water. Similar types of products such as antibacterial wipes, hand sanitizers or other antibacterial products used in healthcare settings are not included.
The agency's decision could have large implications for soap makers. Consumers spend nearly $1 billion a year in antibacterial soaps and other products, according to the Natural Resources Defense Council.
Triclosan in particular has been a common agent used in such products since the 1970s, with studies detecting it in the urine of 75% of those tested, according to the Centers for Disease Control and Prevention.